Trial Outcomes & Findings for Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD) (NCT NCT02725476)

Last Updated: 2018-12-07

Results Overview

Improvement of disease activity as defined by a decrease of IgG4-RD responder index \>= 2 points from Day 1 pre-dose disease activity score. The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline Day 1 to Day 169

Results posted on

2018-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	XmAb5871 5 mg/kg 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose 90 mg or 180 mg fixed dose group
Overall Study STARTED	15	5
Overall Study COMPLETED	12	4
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	XmAb5871 5 mg/kg 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose 90 mg or 180 mg fixed dose group
Overall Study Physician Decision	2	0
Overall Study Adverse Event	1	1

Baseline Characteristics

Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XmAb5871 5 mg/kg n=15 Participants 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose n=5 Participants 90 mg or 180 mg fixed dose group	Total n=20 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 10.57 • n=5 Participants	51.2 years STANDARD_DEVIATION 14.11 • n=7 Participants	57.9 years STANDARD_DEVIATION 11.82 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Serum IgG4 level at Baseline	440.33 mg/dL STANDARD_DEVIATION 622.990 • n=5 Participants	858.60 mg/dL STANDARD_DEVIATION 351.608 • n=7 Participants	544.90 mg/dL STANDARD_DEVIATION 588.674 • n=5 Participants
Involved Areas at Baseline Bile Ducts	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Involved Areas at Baseline Constitutional Symptoms	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Involved Areas at Baseline Heart / Pericardium	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Involved Areas at Baseline Kidney	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Involved Areas at Baseline Lacrimal Glands	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Involved Areas at Baseline Lungs	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Involved Areas at Baseline Lymph Nodes	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Involved Areas at Baseline Nasal Cavity Lesion	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Involved Areas at Baseline Orbital Lesion	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Involved Areas at Baseline Other	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Involved Areas at Baseline Other ENT Lesions, e.g. tonsillitis, pharyngitis	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Involved Areas at Baseline Other Salivary Glands	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Involved Areas at Baseline Pancreas	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Involved Areas at Baseline Parotid Glands	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Involved Areas at Baseline Retroperitoneal Fibrosis	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Involved Areas at Baseline Sinusitis	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Involved Areas at Baseline Skin	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Involved Areas at Baseline Submandibular Glands	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Baseline IgG4-RD Responder Index Total Activity Score	11.5 Total Activity Score STANDARD_DEVIATION 6.65 • n=5 Participants	12.8 Total Activity Score STANDARD_DEVIATION 6.42 • n=7 Participants	11.8 Total Activity Score STANDARD_DEVIATION 6.45 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline Day 1 to Day 169

Population: Intent to Treat (ITT) Population: All patients who have received at least a partial dose of XmAb5871.

Outcome measures

Outcome measures
Measure	XmAb5871 5 mg/kg n=15 Participants 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose n=5 Participants 90 mg or 180 mg fixed dose group
Proportion of Patients With an Improvement in IgG4-RD Activity Responder at Day 169 visit	12 Participants	4 Participants
Proportion of Patients With an Improvement in IgG4-RD Activity Non-Responder at Day 169 visit	2 Participants	0 Participants
Proportion of Patients With an Improvement in IgG4-RD Activity Not Assessed at Day 169 visit	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline Day 1 to Day 197

Population: Safety Population: All patients who receive at least a partial dose of XmAb5871.

The number of patients experiencing a treatment-emergent adverse event as assessed by CTCAE v4.3 will be tabulated according to MedDRA system-organ class and preferred term, intensity and causality.

Outcome measures

Outcome measures
Measure	XmAb5871 5 mg/kg n=15 Participants 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose n=5 Participants 90 mg or 180 mg fixed dose group
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3	13 Participants	5 Participants

Adverse Events

XmAb5871 5 mg/kg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

XmAb5871 Fixed Dose

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	XmAb5871 5 mg/kg n=15 participants at risk 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose n=5 participants at risk 90 mg or 180 mg fixed dose group
Infections and infestations Pneumonia	6.7% 1/15 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	0.00% 0/5 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/15 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	20.0% 1/5 • Number of events 1 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/15 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	20.0% 1/5 • Number of events 1 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).

Other adverse events

Other adverse events
Measure	XmAb5871 5 mg/kg n=15 participants at risk 5 mg/kg weight-based dosing group	XmAb5871 Fixed Dose n=5 participants at risk 90 mg or 180 mg fixed dose group
Gastrointestinal disorders Abdominal pain	20.0% 3/15 • Number of events 5 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	20.0% 1/5 • Number of events 1 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	40.0% 2/5 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	40.0% 2/5 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Gastrointestinal disorders Diarrhoea	13.3% 2/15 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	0.00% 0/5 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
General disorders Chills	13.3% 2/15 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	0.00% 0/5 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Nervous system disorders Headache	13.3% 2/15 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	0.00% 0/5 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.7% 1/15 • Number of events 1 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	20.0% 1/5 • Number of events 1 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
Infections and infestations Upper respiratory tract infection	0.00% 0/15 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).	40.0% 2/5 • Number of events 2 • Day 1 (First Dose) through Day 197 Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).

Additional Information

Vice President, Biometrics

Xencor, Inc.

Phone: 858-480-3414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place